Recruiting
Phase 1

NanO2™

Sponsor:

NuvOx LLC

Code:

NCT06658535

Conditions

Mild Respiratory Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

dodecafluoropentane (0.025 mL/kg)

dodecafluoropentane (0.032 mL/kg)

dodecafluoropentane (0.050 mL/kg)

Study Details

Brief summary:

EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.

Conditions

Mild Respiratory Distress

Study ID

NCT06658535

Start date

Mar 13, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
  • Admitted to a hospital with symptoms of mild RD
  • Signed informed consent obtained from the subject or subject's legally authorized representative
  • Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28

Exclusion Criteria:

  • Presence of extracorporeal membrane oxygenation
  • Unstable hypertension
  • History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
  • Presence of pulmonary embolism at baseline
  • Evidence of right ventricular heart failure
  • Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
  • Inability to comply with the study procedures
  • Currently pregnant or breastfeeding
  • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
  • History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 0.025

Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.

experimental: Cohort 0.032

Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.

experimental: Cohort 0.050

Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.

Interventions

dodecafluoropentane (0.025 mL/kg)

dodecafluoropentane (0.025 mL/kg)

dodecafluoropentane (0.032 mL/kg)

dodecafluoropentane (0.032 mL/kg)

dodecafluoropentane (0.050 mL/kg)

dodecafluoropentane (0.050 mL/kg)

Primary outcome measure

  • Maximum Tolerated Dose [ Time Frame: 28 Days ]

Central Contacts and Locations

Central contacts

NuvOx Pharma

520-624-6688EXTEND_Clinical@nuvoxpharma.com

Locations

Grey Nun Community Hospital

Recruiting

Edmonton, Alberta, Canada, T6L 5X8

Contacts

Anushka Jayasekara

587-590-5295Anushka.Jayasekara@covenanthealth.ca

Principal Investigator:

Janek Senaratne, MD

Hôpital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Danaë Tassy, PhD

514-252-3400danae.tassy.cemtl@ssss.gouv.qc.ca

Principal Investigator:

François Marquis, MD

More Information

Sponsor

NuvOx LLC

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • respiratory distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NuvOx LLC on 2026-01-28.